The invention relates generally to devices for safely alleviating erectile dysfunction. In particular, the invention relates to a device secured around the penis to restrict blood flow out of the penis while providing a visual cue for signaling the level of restriction.
Erectile dysfunction (ED) is a medical condition for which millions of American men seek treatment every year. According to the National Institutes of Health, between 15 million and 30 million men suffer from ED, which is loosely defined as the repeated inability to get or keep an erection firm enough for sexual intercourse. The wide range of the estimate of sufferers stems from the rather vague definition, as ED can be a total inability to achieve erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. Under normal conditions, an erection is achieved when blood flows into the penis and fills the corpora cavernosa, large cylindrical tissue structures which run the length of the penis and, when filled with blood, cause the penis to become rigid and erect. The corpora cavernosa are surrounded by the tunicae, elastic sheaths which expand with the corpora cavernosa and apply pressure to the veins which would normally drain the blood from the corpora cavernosa. In some cases, the cause of ED is linked to an inability to provide sufficient blood flow to the penis to fill the corpora cavernosa and achieve an erection. In other situations, the tunicae are not able to press against the blood-draining veins with sufficient force to maintain the erection.
While many of those afflicted with ED are older, with approximately half of the sufferers believed to be over the age of 65, ED is a condition which can affect men at any age, as the causes of ED are extremely varied. Damage to nerves, arteries, smooth muscles, and fibrous tissues from disease is the most common cause of ED. These diseases, such as diabetes, multiple sclerosis, atherosclerosis, and vascular disease, account for about 70 percent of ED cases. In addition, many common medicines including blood pressure drugs, antihistamines, and antidepressants can result in ED. Certain risky lifestyle choices, such as smoking, being overweight, and avoiding exercise, may also contribute to ED. It is also believed that psychological factors, such as stress, anxiety, depression, and fear of sexual failure, cause approximately 10 to 20 percent of ED cases.
Many methods for alleviating ED are known. For example, surgical treatment options exist. However, these surgeries are radical and invasive, as they involve implanting inflatable members into the penis. These members can be inflated by pumping fluid into the members when sexual intercourse is desired. Due to the cost, side effects, and invasive nature of the surgery, the surgical option is not considered viable by many men, especially those who suffer from a more mild form of the condition.
The pharmaceutical industry has also produced many options for ED sufferers. These drug remedies may be pills or liquids taken orally, such as phosphodiesterase inhibitors which increase blood flow to the penis. Viagra®, Levitra®, and Cialis® are popular phosphodiesterase inhibitors. While popular, these drugs are not suitable for many men, including patients also suffering from heart disease. As the majority of ED sufferers are older men who frequently also have heart disease, oral ED drugs may not be suitable for the majority of ED sufferers. Furthermore, even if an ED sufferer is physically capable of taking the oral drugs, they may not wish to do so, as the drugs can take up to one hour to be effective or can cause priapism, a painful and persistent erection caused by over-constriction of the corpora cavernosa-draining veins.
Other drug options include injecting drugs directly into the penis. Drugs such as papaverine hydrochloride, phentolamine, and alprostadil widen blood vessels to allow more blood to flow into the penis. While these erections are achieved nearly instantaneously, these drugs can cause undesirable side effects, including priapism and scarring. Furthermore, many men may be extremely reluctant to insert a needle into the sensitive skin of the penis.
Mechanical devices are also available for producing and/or maintaining erections. These devices include large, cumbersome vacuum pumps for drawing blood into the penis and restrictors which hold blood in the penis by applying pressure to the subcutaneous veins which drain the penis of blood. Especially for those who suffer from the more mild forms of ED, restrictors are a very popular option. Such restrictors include continuous rigid rings, adjustable straps, or the like. Restrictors are described, for example, in U.S. Pat. No. 5,855,548 (rubber tubing looped around the base of the penis), U.S. Patent Pub. US 2003/0009082 (an adjustable gold ring through which the penis is inserted), U.S. Patent Pub. US 2004/0242957 (an adjustable rigid band encircling a portion of the base of the penis), and U.S. Patent Pub. US 2005/0277907 (joined elastic rings worn around the scrotum and the base of the penis).
While effective in treating ED, especially for mild ED, restrictors also pose certain risks, mostly related to trapping blood within the penis for extended periods of time and over-restricting the vessels of the penis. The Food and Drug Administration has suggested guidelines for using restrictors, also called constriction rings, which include only wearing the restrictor for thirty (30) minutes or less per use, waiting at least an hour between uses, cleaning the restrictor thoroughly between uses, and carefully selecting the properly sized restrictor.
Selecting the properly sized restrictor is extremely critical to effective and safe usage of a restrictor, especially if the restrictor chosen is a rigid continuous ring. If the restrictor is too loose, then the restrictor will not be effective in relieving the symptoms of ED. If the restrictor is too tight, then serious consequences such as permanently damaging the penis, may occur.
Currently, sizing of restrictors is performed by trained personnel, a situation that many in need of restrictors find too embarrassing to endure. As a consequence, many men either deny themselves the restrictors or take the chance that the one they purchase will fit appropriately. Therefore, a need exists for a purchaser of a restrictor to size a restrictor privately. Furthermore, no restrictors currently available include a signal or gauge to let a user know if the restrictor has reached an unsafe level of restriction. Therefore, a need exists for a gauge to signal a user of a restrictor of a potentially hazardous condition.